DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ Preliminary Amendments and Remarks, filed 24 June 2024, in the matter of Application N° 18/723,758. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
No claims have been added or canceled.
Claims 1-4, 7-13, and 15 have been amended. The prominent amendment to the claims is the removal of improper claim dependency language. Additionally, various alternative recitations (e.g., “substantially free” limitations) have been removed from the claims as well.
No new matter has been added.
Thus, claims 1-16 represent all claims currently under consideration.
Information Disclosure Statement
One Information Disclosure Statement (IDS) filed 30 October 2024 is acknowledged and has been considered.
Claim Objections
Claim 7 is objected to because of the should recite that bar composition “further” comprises…” since the claim is adding a zwitterionic surfactant not present in the preceding claim.
Additionally, the preamble to claim 13 recites a “method for reducing both Gram negative and positive antimicrobial presence on a surface…” The Examiner submits that this appears to be a typographical mistake and that the method should be drawn to a method reducing gram negative and positive microbial presence.
Appropriate corrections are required.
Claim Rejections - 35 USC §112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Each of claims 3-6 recites the limitation “the acid” in the first lines of each claim. There is insufficient antecedent basis for this limitation in claim 1, which initially recites the limitation as “at least one acid”.
Claim Rejections - 35 USC §103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the Examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicants are advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the Examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Morikis et al. (US Pre-Grant Publication Nº 2006/0002883 A1; IDS/ISR reference of record) in view of Anathapadmanabhan (Tenside Surf. Det.; 2019) and Monte (Pathogens; 2014).
The instantly claimed invention is directed to a bar composition comprising:
from 18-65 wt% of an anionic surfactant;
from 0.2-8 wt% of at least one acid having a pKa from 1-8 and a logP from 0-4.95; and
from 10-64 wt% bar structurant fatty acid.
Claim 1 additionally recites that the property that the bar composition in a 10% aqueous slurry will have a pH of 2.9-5.2, with the proviso that when the slurry has a pH over 4.45 and the bar composition has 0.5 wt% or less of at least one acid having a pKa from 1-8 and a logP of 0-4.95, the bar composition has less than a total of 3 wt% of a betaine, sultaine derived surfactant, and mixtures thereof, and further comprises no more than 3.5 wt% of a sulfate based on the total weight of the bar composition.
Regrading the limitations of claim 1, the Examiner broadly and reasonably interprets the claim as being drawn to the bar composition itself and not the slurry composition within which the bar is placed. Pursuant to that point, the Examiner additionally submits that the recited pH range of 2.9-5.2 turns on that condition and is not necessarily the pH of the bar composition itself. Beyond the required three components of the claim, the Examiner broadly and reasonably interprets that the composition need not abide by the betaine/sultaine, or sulfate limitations when the amount of acid present in the composition exceeds 0.5 wt% of the total bar composition.
Regarding the structurant fatty acid, the instant specification defines it as being a blend of C8-C18 fatty acids (see Spec., pg. 15, lines 4-6).
Morikis discloses toilet bar compositions comprising both sodium cocoyl isethionate (29.5-47 wt%) and sodium isethionate (5.0 wt%) as anionic surfactants (see e.g., Examples A-G; Table 1). Table 1 also discloses including coconut acid (4-5 wt%), stearic acid (15-20 wt%), and sodium stearate (4wt% or 10wt%) as fatty acid compounds.
The Table does not disclose the inclusion of an active agent such as salicylic acid. However, the broader teachings of the reference do disclose that the practiced bar composition will contain an active agent, such as an anti-acne active, such as salicylic acid (aka o-hydroxybenzoic acid) and that such actives are present in amounts ranging from more preferably 0.1-10 wt% to most preferably, 0.1-5 wt% of the active agent component. See ¶[0115] and ¶[0117].
The disclosure of salicylic acid is considered to inherently meet the limitations, whereby it has an acidic pKa of about 2.8-2.9 and a logP of 2.26 (see e.g., PubChem CID 338; pubchem.ncbi.nlm.nih.gov/compound/Salicylic-Acid). MPEP §2112.01(II) states that “[p]roducts of identical chemical composition cannot have mutually exclusive properties” and that “a chemical composition and its properties are inseparable.”
Lastly, regarding claim 1, none of Examples A-G contain betaine, sultaine, or mixtures thereof (i.e., 0 wt%) and those Examples that do contain sulfates (e.g., calcium or sodium lauryl sulfate), do not contain them in amounts greater than 3.5 wt%.
Further, the reference discloses that the active agent may be present in amounts greater than 0.5 wt% of the composition, thereby negating the need to meet the betaine, sultaine, and sulfate limitations recited by claim 1 and 12.
Claim 8 of the reference further differentiates that the composition will contain two types of anionic surfactant: 20-60 wt% of a synthetic anionic surfactant and 1-10 wt% of anionic surfactants having a Krafft point of about 20ºC or less. Added definition of the synthetic anionic surfactants discloses that this surfactant is also inclusive of taurate surfactants. See ¶[0050], ¶[0057], and ¶[0058].
The foregoing is considered to meet the limitations of claim 2 owing to the breadth of the recitation that the combination of isethionate and taurate surfactants present in the instant composition ranges from 1:99 to 99:1 weight ratio of the two surfactants. The reference also discloses the recited range of 20-60 wt% of anionic surfactant.
The limitations of claims 3-6 are read on by the foregoing disclosure of salicylic acid (aka o-hydroxybenzoic acid). See ¶[0117].
The limitations of claim 7 recite that the composition of claim 1 further comprises a zwitterionic (amphoteric) surfactant in an amount ranging from 0.00001 to 3.0 wt% and that the zwitterionic surfactant is a betaine, sultaine, or combination thereof. The Examiner further infers that the claim narrows the amount of acid in claim 1 to a range of 0.2-0.5 wt% of the bar composition, based on the conditional limitations set forth in the preceding claim.
The reference discloses meeting the required active agent amount required by claim 7 as discussed above.
Furthermore, the reference discloses that amphoteric surfactants are advantageously present in amounts ranging from 1-3% by weight to about 5-7% by weight of the composition. See ¶[0063]. Amphoteric surfactants are further defined as including betaines and sulphobetaines (aka sultaines). See ¶[0070] and ¶[0074].
The limitations recited by claim 8 narrow the recited composition of claim 7, such that the composition further comprises from 0.001-3.5 wt% of a taurate.
The limitation is considered to be met by the foregoing disclosure of anionic surfactants having a Krafft point of about 20ºC or less being present in an amount of about 1-10 wt% (see e.g., claim 8). As evidenced by the state of art regarding amino-acid surfactants, taurates such as sodium lauroyl taurate have a Krafft point that is below RT or room temperature (see e.g., Table 2 of Anathapadmanabhan). The article further discusses the factors that determine the Krafft point of a given amino acid surfactant, which includes a balance between hydrophobic and hydrophilic groups. Thus, the shorter the hydrophobic group (i.e., the shorter the carbon length), the lower the Krafft point temperature (see e.g., Anathapadmanabhan, pg. 380, section 3.1).
What this conveys to the person of ordinary skill in the art with respect to the disclosure of Morikis is that the use of taurates as the low Krafft point anionic surfactants is taught and suggested, and within the range as instantly claimed. The practiced range of about 1-10 wt% of this type of surfactant overlaps that which is instantly claimed, thereby rendering it prima facie obvious. See MPEP §2144.05(I).
The limitations recited by instant claim 9 require that the composition comprise less than 9 wt% of soap and that the composition is “substantially free” (i.e., no more than 3.5 wt%) of ethanol, paraben, formaldehyde donor, silicone, glycinate and/or halogenated antimicrobial additive.
Regarding the contribution of soap, the Examiner acknowledges the previously relied upon disclosure of Table 1 (Examples A-G) and notes that these compositions disclose amounts of tallow/coco soap that exceeds 9 wt%. However, the broader teachings of the reference provide that this range of soap may be as low as 2 wt% of the composition (see e.g., claims 1 and 8; ¶[0042]). Paragraph [0042] discloses further that a preferred amount of the soluble soaps may comprise about 2-10 wt% of the final bar.
Further, practiced invention is silent as to the inclusion of ethanol and glycinate. Parabens are an optional preservative which may be included in the bar composition. See ¶[0094]. Silicone oils are also an optional ingredient. See ¶[0099]. Lastly, antimicrobial agents that are halogenated (e.g., triclosan) are also disclosed as optional inclusions. See ¶[0118].
The limitations of claim 10 recite similar inclusion limitations stating that the composition will contain less than 3.5 wt% of silicone, C16-C18 methyl ester sulphonate, glycinate, carboxylate, glutamates, and/or alpha olefin sulfonate, wherein the composition has a zein value ≤10.
As discussed above, the composition does not include glycinate. The reference is also silent to glutamates and C16-C18 methyl ester sulphonates. Alkali metal carboxylates are optional per ¶[0043]. Lastly, alpha olefin sulfonates are disclosed as optional anionic surfactants having a Krafft point of 20ºC or less. See ¶[0024].
The limitation pertaining to the zein value is not expressly disclosed by the reference, but is disclosed as being most preferably less than 25. See ¶[0212]. However, since the compositional merits of the claimed invention have been shown to be met by the reference, the Examiner respectfully advances that the recited zein value property has also been met absent a clear showing of evidence to the contrary. MPEP §2112.01(I) states that “[w]here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.”
The limitations of claim 11 recite that the composition further comprises other such compounds as species of cationic surfactants, 12-hydroxystearic acid, benzalkonium chloride, antimicrobial lipids or peptides, triclosan, thymol, terpineol, or combinations thereof.
As mentioned above, triclosan is disclosed in ¶[0118] as an alternative species of halogenated antimicrobial active agent. Paragraph [0044] also discloses that stearic acids with an alkali metal hydroxide is available as an optional neutralizing fatty acid. Thymol is disclosed as an optional essential oil in ¶[0099], part (f).
Additionally, the practiced invention discloses using cationic surfactants, which are taught as including cetylpyridinium chloride and cetrimonium bromide (aka cetyl trimethyl ammonium bromide or CTAB). See Parran (USPN 3,723,325; col. 5, lines 18-24). Parran is incorporated by reference at ¶[0091] of Morikis.
The limitations of independent claim 13 recite reducing both gram negative and positive antimicrobial presence on a surface comprising: (a) contacting said surface with a “bar slurry” comprising: 60-99 wt% water, and 1-40 wt% water soluble or insoluble components, and (b) rinsing the slurry from the surface.
The limitations recited by claim 14 require that the surface to which the composition is applied is hair, skin, or an inanimate object.
Claim 15 further limits the applied composition such that it contains 0.0% by weight of taurate, betaine, sultaine, or soap.
The compositional merits of the applied composition are taught above. Regarding the recited method, Morikis discloses that the practiced compositions are used as compositions for cleansing the human body, such as the skin and hair, and that use of the composition creates a lather that is fast-rinsing, and confers a squeaky-clean feel to the skin.
Regarding the efficacy of the instant composition against E. coli and S. aureus, the reference does not expressly disclose those organisms against which the practiced composition demonstrates antimicrobial efficacy. However, as discussed above, the reference does teach and suggest that active ingredients which may be incorporated into the bar include, for instance, salicylic acid (aka o-hydroxybenzoic acid).
The teachings of Monte are relied upon here to establish that salicylic acid not only demonstrates antimicrobial activity, but specifically activity against both E. coli and S. aureus. Therein, Table 1 (pg. 476) of the reference depicts both the minimum inhibitory and minimum bactericidal concentrations (MIC) and (MBC) for salicylic acid (SA). The Examiner acknowledges that the reference teaches that there are two other compounds comparatively tested that provide better MIC and MBC against the tested organisms. However, the reference is simply being relied upon to define salicylic acid as possessing the instantly claimed property.
Based on the combined teachings of the references, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success at producing the instantly claimed composition and arriving at the recited method of reducing both Gram negative and positive microbial presence in a surface to which the composition is applied.
As discussed above, the teachings of Morikis, with supplemental definitions provided either incorporated therein or by the state of the art, teach and suggest the instantly claimed composition. Morikis further discloses that the practiced bar composition is applied with water to form a lather on the human body (i.e., skin and/or hair) to cleanse said surface and then to rinse it away.
The supplemental teachings of Monte provide the skilled artisan with motivation to select salicylic acid as the active agent to include in the composition of Morikis with the understanding that the compound acts as an antimicrobial agent against both gram negative and gram-positive organisms such as E. coli and S. aureus.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 pm; M-F (EST).
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615
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